MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER MINIBAG PLUS 100 ML; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC

Lot Number P411157

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

Minibag plus device is not working as intended.When pulling off the foil the plastic on the adapter is not releasing.Fda safety report id # (b)(4).

• Brand Name: BAXTER MINIBAG PLUS 100 ML
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11648177
• MDR Text Key: 245187548
• Report Number: MW5100698
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Lot Number: P411157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1